Press Release: Amplexor Life Sciences joined Aris Global family, Creating the Most Comprehensive Regulatory SaaS Platform for the Industry

Press Release: Amplexor Life Sciences joined Aris Global family, Creating the Most Comprehensive Regulatory SaaS Platform for the Industry

Press Release: Amplexor Life Sciences joined Aris Global family, Creating the Most Comprehensive Regulatory SaaS Platform for the Industry

The complementary pairing of these two leading Regulatory companies brings an unmatched offering to the global market.

Miami, U.S.; Novo mesto, Slovenia, February 28, 2023  ArisGlobal, the leading provider of life sciences software designed to automate core drug development functions with its end-to-end technology platform LifeSphere® today announces the acquisition of Amplexor Life Sciences (LS), a global provider of regulatory, quality, and safety software solutions, serving and trusted by pharmaceutical, biotechnology, and medical device companies.  

The integration of the regulatory product lines will bring a distinct set of benefits to customers. LifeSphere users are now gaining access to enhanced publishing and labeling capabilities; in addition to a robust Quality Management System (QMS) from Amplexor LS.  Amplexor LS’s regulatory customers can now connect to even wider functionality through ArisGlobal’s market leading LifeSphere platform including access to state-of-the-art Safety, Medical Affairs and Clinical solutions.  

This combined product ecosystem provides a new opportunity for life sciences companies, bringing together best in breed solutions to form a cohesive solution serving customers’ regulatory needs. It also represents many years of industry expertise, software innovation, and customer excellence from ArisGlobal and Amplexor Life Sciences. This move will accelerate both companies’ roadmaps and increase efficiency in bringing new therapies to the market.  

“For many years, ArisGlobal has been focused on building a regulatory platform that provides a market-leading, comprehensive set of products and streamlines processes supporting collaboration across distributed teams while adhering to extensive and evolving global regulatory requirements,” shares Mike Gordon, chief executive officer at ArisGlobal. “By combining our core functionalities, we are elevating our end-to-end Regulatory capabilities to enhance our customers’ journey.”

“Amplexor Life Sciences has always sought to provide their customers with operational excellence in global compliance, and this new chapter of our products within the LifeSphere Regulatory platform will continue to do that,” states Elvis Paćelat, Executive Vice President at Amplexor LS. “We are excited to join forces with ArisGlobal, who has been an innovator in the life sciences space for several decades, to provide the market with a full scope of products designed to make regulatory processes a connected, cloud-based, and compliant experience.”    

“The vision and objectives of ArisGlobal and Amplexor LS are aligned”, shares Jim Hilferty, AVP and Head of Regulatory at ArisGlobal. “We’re confident that bringing our organizations together will serve as a catalyst for innovation to benefit life sciences, and allow us to deliver the most intelligent, connected, and comprehensive platform available to the regulatory community.”

Both companies have been supporting R&D processes through technology for decades, with offices throughout Europe, United States, India, and the APAC region.   

The integration is subject to customary government approvals that are expected to be completed in the next 60 days.  Further information will be made available on the combined solution.   

For more information, visit arisglobal.com and amplexorlifesciences.com 

Holistic RIM: Maximizing the value of regulated data

Holistic RIM: Maximizing the value of regulated data

WEBINAR ON DEMAND

Holistic RIM: Maximizing the value of regulated data

This webinar will provide: 

  • The arguments for data centricity in regulatory information management, including data-first processes and workflows, are already well accepted. But what many companies don’t realize yet is that next generation holistic RIM solutions can make a difference in maximizing the value of regulated data in Life Sciences companies
  • Such solutions can provide a clear and actionable ‘big picture’ of this fairly complex, granular and inter-related domain. Such capability can determine companies’ ability to do more with their data – transforming the way they re-use it, maintain and improve its quality, and facilitate and ease lifecycle management activities
  • Using examples of what’s possible, Amplexor’s Agnes Cwienczek and Renato Rjavec will explore those potentials in this webinar

 

 

About the speakers
Renato Rjavec

Renato Rjavec

Director of Product Management

As Director of Product Management, Renato is responsible for Amplexor Life Sciences Solution Product Management. Over the last fifteen years with the company, he held several positions within the delivery and product management organization where he acquired broad experience in analyzing, designing and implementing end-to-end regulatory solutions for the global Life Sciences industry.

Agnes Cwienczek

Agnes Cwienczek

Head of Product Management & Consulting

Agnes has been in the position of ALSS Head of Product Management and Consulting since May 2017. Her main responsibilities are the contribution to the development and enhancement of the Amplexor Life Sciences Suite, supervision of the Life Sciences Consultants as well as the provision of business process and data management expertise to Amplexor clients in Regulatory Information Management, Document Management, and Submission Management.

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Amplexor Life Sciences to exhibit at forthcoming Indian Pharma Regulatory Summit 2023

Amplexor Life Sciences to exhibit at forthcoming Indian Pharma Regulatory Summit 2023

We will be exhibiting at this year’s Pharma Regulatory Summit 2023. Amplexor executives will be on hand to discuss some of the Indian industry’s latest developments.

The sixth Annual Pharma Regulatory Summit 2023 brings together leading global pharmaceutical industry professionals and regulators to share their insights on technologies, approaches and solutions that will drive innovation and quality for medicines delivered to patients worldwide. This interactive setting with expert-led regulatory and industry presentations and forums will ensure pharmaceutical industry professionals are well-prepared to develop and apply innovative solutions in today’s global regulatory environment.

The event will feature a range of key themes to be discussed, including Indian pharma regulations; regulatory compliance; remote clinical development; prioritizing patient safety; medical devices; and Indian product registration.

“The Indian market is currently the source of much attention so we are naturally delighted to join this exciting event to explore all the market has to offer,” comments Elvis Paćelat, Executive Vice President, Amplexor Life Sciences. “Please come and visit our experienced team to find out what services and products we currently offer in India and how we can help your business thrive.”

The event takes place on 28th March at the Hotel Kohinoor Continental, Mumbai, India. If you would like to register for the meeting with our representatives at Indian Pharma Regulatory Summit 2023, please fill out this form.

 

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Today,  Amplexor Life Sciences joined ArisGlobal to be part of the LifeSphere story.

Today,  Amplexor Life Sciences joined ArisGlobal to be part of the LifeSphere story.

ArisGlobal Signs Agreement to Acquire Amplexor Life Sciences, Creating the Most Comprehensive Regulatory SaaS Platform for the Industry

The complementary pairing of these two leading Regulatory companies brings an unmatched offering to the global market.

Miami, U.S.; Novo mesto, Slovenia, February 28, 2023ArisGlobal, the leading provider of life sciences software designed to automate core drug development functions with its end-to-end technology platform LifeSphere® today announces the acquisition of Amplexor Life Sciences (LS), a global provider of regulatory, quality, and safety software solutions, serving and trusted by pharmaceutical, biotechnology, and medical device companies.  

 The integration of the regulatory product lines will bring a distinct set of benefits to customers. LifeSphere users are now gaining access to enhanced publishing and labeling capabilities; in addition to a robust Quality Management System (QMS) from Amplexor LS.  Amplexor LS’s regulatory customers can now connect to even wider functionality through ArisGlobal’s market leading LifeSphere platform including access to state-of-the-art Intelligent Content management, Safety, Medical Affairs and Clinical solutions.  

This combined product ecosystem provides a new opportunity for life sciences companies, bringing together best in breed solutions to form a cohesive solution serving customers’ regulatory needs. It also represents many years of industry expertise, software innovation, and customer excellence from ArisGlobal and Amplexor Life Sciences. This move will accelerate both companies’ roadmaps and increase efficiency in bringing new therapies to the market.  

 “For many years, ArisGlobal has been focused on building a regulatory platform that provides a market-leading, comprehensive set of products and streamlines processes supporting collaboration across distributed teams while adhering to extensive and evolving global regulatory requirements,” shares Mike Gordon, chief executive officer at ArisGlobal. “By combining our core functionalities, we are elevating our end-to-end Regulatory capabilities to enhance our customers’ journey.”

“Amplexor Life Sciences has always sought to provide their customers with operational excellence in global compliance, and this new chapter of our products within the LifeSphere Regulatory platform will continue to do that,” states Elvis Paćelat, Executive Vice President at Amplexor LS. “We are excited to join forces with ArisGlobal, who has been an innovator in the life sciences space for several decades, to provide the market with a full scope of products designed to make regulatory processes a connected, cloud-based, and compliant experience.”    

“The vision and objectives of ArisGlobal and Amplexor LS are aligned”, shares Jim Hilferty, AVP and Head of Regulatory at ArisGlobal. “We’re confident that bringing our organizations together will serve as a catalyst for innovation to benefit life sciences, and allow us to deliver the most intelligent, connected, and comprehensive platform available to the regulatory community.”

Both companies have been supporting R&D processes through technology for decades, with offices throughout Europe, United States, India, and the APAC region.   

The integration is subject to customary government approvals that are expected to be completed in the next 60 days.  Further information will be made available on the combined solution.   

For more information, visit arisglobal.com and amplexorlifesciences.com  

###  

About ArisGlobal & LifeSphere:   

ArisGlobal is the market leader in Drug Safety solutions worldwide and is transforming the way today’s most successful Life Sciences companies develop breakthroughs and bring new products to market. Headquartered in the United States, ArisGlobal has regional offices in Europe, India, Japan, and China. For more updates, follow ArisGlobal on LinkedIn and Twitter.  

About Amplexor Life Sciences:   

Amplexor Life Sciences is a global provider of regulatory, quality and safety software solutions, serving and trusted by pharmaceutical, biotechnology and medical device companies for over 30 years. Its holistic Life Sciences Suite of solutions helps life sciences organizations to be efficient with launching products and breaking into new markets quickly while ensuring quality, efficacy and safety through end-to-end support to product lifecycle processes, data and content management. 

 

Press contact ArisGlobal:  

Erika Thomas/Maegan Ratts

Ethomas@arisglobal.com 

Arisglobal@blastmedia.com 

  

Press contact Amplexor Life Sciences:  

Iva Klarica

iva.klarica@amplexor.com

Visit us at DIA North Bethesda

Visit us at DIA North Bethesda

Visit us at DIA North Bethesda

We will be exhibiting at the this year’s DIA Regulatory Submissions, Information, and Document Management (RSIDM) Forum. Senior Amplexor executives will be available to explore some of the industry’s most pressing questions.

The Forum features four tracks: Regulatory Informatics, Trial Master File (TMF) Inspection Readiness and Electronic Document Management (EDM), and Electronic Regulatory Submissions (ERS). Cross-track sessions will allow the discussion of key connections across major components of regulatory information, while daily plenary sessions will showcase regulatory intelligence updates by FDA and other regulatory authorities.

The RSIDM Forum will also provide multiple opportunities for networking, knowledge sharing, and education for both business and technology-focused attendees. Together, they will debate the scope of regulatory information when it comes to evolving data standards as well as the effective regulatory information management approaches needed to align related people, processes, and technology.

“We are delighted to bring Amplexor Life Sciences to the Forum in person where our experienced subject experts will be on hand to discuss the latest industry trends,” comments Elvis Paćelat, Executive Vice President, Amplexor Life Sciences. “We would invite anyone who would like to explore the implications of Regulatory Informatics, EDM and TMF, and ERS in the context of current industry trends to visit us at Booth 205.”

The event takes place on 13-15 February at the Bethesda North Marriott Hotel and Conference Center in North Bethesda, Maryland. The Amplexor Life Sciences team can be found at Booth 205. 

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